(PD-1/CTLA-4 Bi-specific Antibody, Cadonilimab Injection)
开坦尼® (Cadonilimab injection) is a novel, first-in-class PD-1/CTLA-4 bi-specific immunotherapy drug in-house developed by the Company, which is mainly used in the treatment of gastric cancer, liver cancer, cervical cancer, renal cancer and other malignant tumors. The research data show that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab demonstrates promising safety profile and efficacy.
On June 29th, 2022, 开坦尼® has been granted marketing approval by the NMPA of China for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Currently, a global phase III trial of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has completed patients enrollment, and a Phase III pivotal registry clinical trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is ongoing. In addition, two phase III trials of Cadonilimab to treat early-stage hepatocellular carcinoma (HCC) and gastric (G) or gastroesophageal junction (GEJ) cancer are also ongoing.
PD-1 Monoclonal Antibody, Penpulimab injection
安尼可 ® (PD-1 Monoclonal Antibody, Penpulimab monoclonal antibody injection) is currently the world’s only differentiated PD-1 monoclonal antibody that applies the IgG1 subtype with modified Fc-nulldomain, which can more effectively enhance immunotherapeutic efficacy and reduce immune-related adverse reactions. It is used in the treatment of major diseases such as lymphoma, nasopharyngeal cancer, lung cancer, liver cancer, and gastric cancer, with improved safety and efficacy as demonstrated in clinical studies.
安尼可 ® has been approved by the National Medical Products Administration of China (NMPA) for the treatment of relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) after at least second-line systemic chemotherapy. Meanwhile, the marketing applications of 安尼可 ® for the third-line treatment of metastatic nasopharyngeal cancer and 安尼可 ® plus chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer were submitted in China in July and August 2021 respectively. In addition, the clinical trials of 安尼可 ® for the treatment of liver cancer and gastric cancer are being efficiently advanced.